Zypelor® forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ZIPELOR® FORTE (ZIPELOR FORTE)

Composition:

Active substance: benzydamine;

1 ml of spray contains benzidamine hydrochloride 3.0 mg;

Excipients: ethanol 96%, glycerin, methylparaben (E 218), sodium saccharin, macrogol glycerol hydroxystearate, peppermint flavor, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear, colorless liquid with a characteristic minty odor.

Pharmacotherapeutic group. Agents for use in dentistry. Other agents for local application in the oral cavity.

ATC code A01AD02.

Pharmacological properties.

Pharmacodynamics.

Benzidamine is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-exudative properties.

Clinical studies have demonstrated that benzidamine is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzidamine exerts anti-inflammatory and local analgesic effects on the mucous membranes of the oral cavity.

Pharmacokinetics.

Absorption through the mucous membranes of the oral cavity and pharynx has been confirmed by the presence of measurable amounts of benzidamine in human plasma. However, these levels are insufficient to produce any systemic pharmacological effect. Excretion occurs mainly via the urine, primarily in the form of inactive metabolites or conjugated compounds.

It has been shown that topical application leads to accumulation of an effective concentration of benzidamine in inflamed tissues due to its ability to penetrate through the mucous membrane.

Clinical characteristics.

Indications.

Symptomatic treatment of irritations and inflammations of the oropharynx; pain associated with gingivitis, stomatitis, pharyngitis; in dentistry, used after tooth extraction or for prophylactic purposes.

Contraindications.

Hypersensitivity to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interactions.

Interaction studies have not been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and a physician should be consulted for appropriate management.

In some patients, oral or pharyngeal mucosal ulcers may be caused by serious underlying pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other new symptoms, should seek medical advice from a physician or dentist.

Benzidamine is not recommended for patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).

The use of this medicinal product may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients must be warned accordingly.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

For athletes: the use of medicinal products containing ethanol may lead to a positive doping test.

This medicinal product contains methylparaben (E 218), which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding

There are currently insufficient data available on the use of benzidamine in pregnant or breastfeeding women. It is not known whether this product is excreted in human milk. Animal studies are insufficient to draw conclusions regarding the effects of this product during pregnancy or breastfeeding. The potential risk to humans is unknown.

Zipelor® forte should not be used during pregnancy or breastfeeding.

Effect on ability to drive and use machines

When used at recommended doses, this medicinal product has no influence on the ability to drive or operate machinery.

Method of Administration and Dosage

Attach the spray pump in working position.

Pressing the pump produces an aerosol containing 1 spray dose – 0.17 mL, corresponding to 0.51 mg of benzidamine hydrochloride.

Dosing

Adults: 2–4 sprays 2–6 times daily.

Do not exceed the recommended doses.

Children

The product must not be used in children (under 18 years of age).

Overdose

There have been no reports of overdose with benzidamine following topical administration.

In case of accidental ingestion of a large amount of benzidamine (> 300 mg), especially in children, poisoning may occur. Characteristic signs of overdose after ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system effects (such as dizziness, hallucinations, excitement, convulsions, tremor, increased sweating, ataxia, anxiety, and irritability).

Such acute overdose requires immediate gastric lavage, treatment of fluid and electrolyte imbalances, symptomatic therapy, and adequate hydration.

Adverse reactions.

Undesirable effects are classified according to their frequency of occurrence: very common (≥ 1/10); common (from ≥ 1/100 to < 1/10); uncommon (from ≥ 1/1000 to < 1/100); rare (from ≥ 1/10,000 to < 1/1000); very rare (<1/10,000); frequency not known (cannot be estimated based on available data).

Within each frequency group, adverse effects are listed in order of decreasing severity.

Gastrointestinal disorders: rare – burning sensation in the mouth, dry mouth; frequency not known – oral hypoaesthesia, nausea, vomiting, swelling and discoloration of the tongue, taste alteration.

Immune system disorders: rare – hypersensitivity reaction; frequency not known – anaphylactic reaction.

Respiratory, thoracic and mediastinal disorders: very rare – laryngospasm; frequency not known – bronchospasm.

Skin and subcutaneous tissue disorders: uncommon – photosensitivity; very rare – angioneurotic edema; frequency not known – rash, itching, urticaria.

Nervous system disorders: frequency not known – dizziness, headache.

Shelf life. 2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

15 ml or 30 ml in a bottle. 1 bottle in a box.

Supply category. Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's address and location of its business activity.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.